Human Immunodeficiency Virus (HIV) ProphylaxisEarly Phase 1NCT02431273

Safety and Pharmacokinetic Study of HIV Prophylaxis Using Antiretroviral Intravaginal Rings in Healthy Women

A Early Phase 1 study testing TDF IVR, TDF-FTC IVR and TDF-FTC-MVC IVR in people with Human Immunodeficiency Virus (HIV) Prophylaxis, run by Auritec Pharmaceuticals at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This study will evaluate the hypothesis that intravaginal rings (IVRs) can safely and in a sustained fashion, deliver the antiretroviral (ARV) drugs - tenofovir disoproxil fumarate (TDF), emtricitabine (FTC), and maraviroc (MVC), in healthy women when used in the following drug combinations: 1) TDF ("Single" IVR); 2)… Read more about this study

Who is it for?: Ages 18 to 45 years, women onlyHealthy volunteers can take part
Conditions the study is for: Human Immunodeficiency Virus (HIV) Prophylaxis
What is being tested?: TDF IVR, TDF-FTC IVR and TDF-FTC-MVC IVR
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 10 participants
Where: 1 siteUnited States
Study dates: Jun 2015to Dec 2016
Phase: Early Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 45 years
Women only
Healthy volunteers accepted
Adult

Who may be able to join

Provides written informed consent
Healthy female 18-45 years of age
HIV negative per subject report and results of screening examination
Negative for sexually transmitted diseases in the past 3 months and at screening exam
No history of genital herpes simplex I or II per subject report
Currently using contraception with plans to continue throughout the study duration or having sex with females only

Show all 10Show fewer

Pre-menopausal with a regular menstrual cycle with at least 21 days between menses and no history of intermenstrual bleeding or with suppressed menstrual cycle by hormonal contraception such as Depo-Provera or continuous oral contraceptive agents
Subjects must agree to abstain from vaginal, anal, and oral sex throughout the first week of each dosing period and then use condoms for vaginal/rectal intercourse until after the final visit for use of each IVR
Subjects must agree to not douche or use any vaginal product other than the Single, Dual and Triple ARV IVRs, including lubricants, feminine hygiene products, and vaginal drying agents throughout the dosing period and until after the final visit
Subjects must agree to blood draws and vaginal exams throughout the course of the study

Who cannot join

HIV positive by subject report or results of screening examination
Positive history for autoimmune disease
Abnormal genital exam defined as grade 1 or higher adverse event by DAIDS genital AE grading table
Abnormal ALT or AST or Hepatitis B infection
Active vaginal infection as determined by site IoR
Abnormal renal function (defined as a creatinine clearance of <50mL/min/1.73 m2)

Show all 14Show fewer

Pregnant or less than 6 months post-partum or current lactation
Current use of an IVR (i.e., Nuvaring, Estring, Femring)
History of TDF, FTC, and MVC use and/or adverse reaction to any of these drugs
History of adverse reaction to silicone
History of toxic shock syndrome
Currently receiving chemotherapy or immunosuppressive agents
Use of investigative drugs within 30 days or 5 half-lives
Currently using or suspected to be using non-therapeutic injection drugs

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Texas Medical Branch
Galveston, Texas, 77555-0587

Other trials in United States

About this study

Official title: Open-Label Safety and Pharmacokinetic Study of Single (TDF), Dual (TDF-FTC), and Triple ARV IVR (TDF-FTC-MVC) in Healthy Women

TDF = tenofovir disoproxil fumarate; FTC = emtrcitabine; MVC = maraviroc

Read the detailed description

The broad long term goal of this project is to empower women to protect themselves from HIV through woman-controlled sustained local delivery of ARTs via intravaginal rings. The short-term general investigational plan is to evaluate IVRs releasing TDF, TDF-FTC and TDF-FTC-MVC in healthy women for up to 7 days in an open-label study to determine safety and drug concentrations in plasma and cervicovaginal lavage and secretions. Additional exploratory studies will be considered and planned based in part on the results obtained in this study. The long-term investigational plan is to evaluate the safety and efficacy of sustained release TDF, TDF-FTC and TDF-FTC-MVC for their ability to decrease HIV transmission to vulnerable women.

Conditions: Human Immunodeficiency Virus (HIV) Prophylaxis
Being tested: TDF IVR, TDF-FTC IVR, TDF-FTC-MVC IVR
Keywords: TDF, FTC, MVC, TDF-FTC, TDF-FTC-MVC, IVR, ARV
Medical subject headings: Acquired Immunodeficiency Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

TDF IVRDrug
Also called Single IVR
TDF-FTC IVRDrug
Also called Dual IVR
TDF-FTC-MVC IVRDrug
Also called Triple IVR

Study groups in NCT02431273
Study group	Role	What they receive
TDF (Single IVR)	Experimental	All subjects will be asked to wear "Single" (TDF) IVRs for 7 days. Receives: Drug: TDF IVR
TDF-FTC (Dual IVR)	Experimental	If the TDF IVR is determined as safe, study participants will be asked to replace it with "Dual" (TDF-FTC) IVRs for 7 days. There will be follow-up visit between removal of a single IVR and replacing it with a dual IVR. Receives: Drug: TDF-FTC IVR
TDF-FTC-MVC (Triple IVR)	Experimental	If the TDF-FTC IVR is determined as safe, study participants will be asked to replace them with "Triple" (TDF-FTC-MVC) IVRs for 7 days. There will be follow-up visit between removal of a dual IVR and replacing it with a triple IVR. Receives: Drug: TDF-FTC-MVC IVR

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants With Specific Graded Adverse Events in Single, Dual, and Triple Antiretroviral (ARV) Intravaginal Rings (IVRs)
Number of Adverse Events (AEs) was recorded. Safety parameters were monitored for each IVR combination and the grading scale for each parameter followed the Female Genital Grading Table for Use in Microbicide Studies. AEs not included in that table were graded using the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 2.0, November 2014 (Grade 1 = mild, Grade 2 = Moderate, Grade 3 = Severe, Grade 4 = Potentially Life-Threatening).
Measured: Days 0-21 following insertion of each IVR.
Pharmacokinetics of the Single, Dual and Triple ARV IVRs: Cervicovaginal Fluid (CVF)
Drug concentrations [tenofovir (TFV), tenofovir disoproxil fumarate (TDF), emtricitabine (FTC) and maraviroc (MVC)] in cervicovaginal fluids (CVF) for each IVR combination.
Measured: Time points at which outcome measure was assessed are Days 2 (after IVR insertion) and 7 (day of IVR removal).
Pharmacokinetics of the Single, Dual and Triple ARV IVRs: Cervicovaginal Lavage (CVL)
Drug concentrations [tenofovir disoproxil fumarate (TDF), emtricitabine (FTC) and maraviroc (MVC)] in cervicovaginal lavage (CVL) were evaluated for each IVR combination.
Measured: Time points at which outcome measure was assessed are Days 2 (after IVR insertion) and 7 (day of IVR removal).
Pharmacokinetics of the Single, Dual and Triple ARV IVRs: Vaginal Tissue
Drug concentrations [tenofovir disoproxil fumarate (TDF), tenofovir (TFV), tenofovir diphosphate (TFV-DP), emtricitabine (FTC) and maraviroc (MVC)] in vaginal tissue (VT) were evaluated for each IVR combination.
Measured: Time points at which outcome measure was assessed are Days 2 (after IVR insertion) and 7 (day of IVR removal).
Pharmacokinetics of the Single, Dual and Triple ARV IVRs: Plasma
Drug concentrations [tenofovir disoproxil fumarate (TDF), emtricitabine (FTC) and maraviroc (MVC)] in plasma were evaluated for each IVR combination.
Measured: Time points at which outcome measure was assessed are Days 2 (after IVR insertion) and 7 (day of IVR removal).
Pharmacokinetics of the Single, Dual and Triple ARV IVRs: Terminal Half-life
Drug concentrations [tenofovir disoproxil fumarate (TDF), emtricitabine (FTC) and maraviroc (MVC)] in terminal half-life were evaluated for each IVR combination.
Measured: Time points at which outcome measure was assessed are Day 7 (day of IVR removal) and daily up to 14 days.

Secondary outcomes (1)

Acceptability of the IVRs
Acceptability of the IVRs was assessed through reported willingness to use the IVR for 28 days in a real-world setting on a likert scale, 1 being "not at all confident" to 5 being "completely confident" for Periods 1 and 2.
Measured: Days 0-21 following insertion of each IVR.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jun 2015Dec 2016

First posted1 May 2015 (estimated)
Study startJun 2015
Primary completionDec 2016
Study completionDec 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Human Immunodeficiency Virus (HIV) ProphylaxisStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Early Phase 1
Primary purpose: Prevention
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 10 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02431273
Sponsor's protocol ID: ARV-IVR 01
Other IDs: 2R44HD075636-02
Status last verified: Jun 2019
First submitted: 4 Aug 2014
Last updated: 2 Jul 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Vincent KL, Moss JA, Marzinke MA, Hendrix CW, Anton PA, Pyles RB, Guthrie KM, Dawson L, Olive TJ, Butkyavichene I, Churchman SA, Cortez JM Jr, Fanter R, Gunawardana M, Miller CS, Yang F, Rosen RK, Vargas SE, Baum MM. Safety and pharmacokinetics of single, dual, and triple antiretroviral drug formulations delivered by pod-intravaginal rings designed for HIV-1 prevention: A Phase I trial. PLoS Med. 2018 Sep 28;15(9):e1002655. doi: 10.1371/journal.pmed.1002655. eCollection 2018 Sep.
PubMed 30265679
Moss JA, Butkyavichene I, Churchman SA, Gunawardana M, Fanter R, Miller CS, Yang F, Easley JT, Marzinke MA, Hendrix CW, Smith TJ, Baum MM. Combination Pod-Intravaginal Ring Delivers Antiretroviral Agents for HIV Prophylaxis: Pharmacokinetic Evaluation in an Ovine Model. Antimicrob Agents Chemother. 2016 May 23;60(6):3759-66. doi: 10.1128/AAC.00391-16. Print 2016 Jun.
PubMed 27067321

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 2 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Open-Label Safety and Pharmacokinetic Study of Single (TDF), Dual (TDF-FTC), and Triple ARV IVR (TDF-FTC-MVC) in Healthy Women
ClinicalTrials.gov ID: NCT02431273
Acronym / sponsor ID: ARV-IVR 01
Conditions: Human Immunodeficiency Virus (HIV) Prophylaxis
Keywords: TDF, FTC, MVC, TDF-FTC, TDF-FTC-MVC, IVR, ARV
Phase: Early Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 10 participants (actual)
Lead sponsor: Auritec PharmaceuticalsIndustry (pharma, biotech, devices)
Collaborators: The University of Texas Medical Branch, Galveston, Oak Crest Institute of Science, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Study start: Jun 2015 (actual)
Primary completion: Dec 2016 (actual)
Study completion: Dec 2016 (actual)
First posted: 1 May 2015 (estimated)
Results: Posted 2 Jul 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

TDF = tenofovir disoproxil fumarate; FTC = emtrcitabine; MVC = maraviroc

Detailed description

Study design

Primary purpose: Prevention
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
TDF (Single IVR)	Experimental	Drug: TDF IVRAll subjects will be asked to wear "Single" (TDF) IVRs for 7 days.
TDF-FTC (Dual IVR)	Experimental	Drug: TDF-FTC IVRIf the TDF IVR is determined as safe, study participants will be asked to replace it with "Dual" (TDF-FTC) IVRs for 7 days. There will be follow-up visit between removal of a single IVR and replacing it with a dual IVR.
TDF-FTC-MVC (Triple IVR)	Experimental	Drug: TDF-FTC-MVC IVRIf the TDF-FTC IVR is determined as safe, study participants will be asked to replace them with "Triple" (TDF-FTC-MVC) IVRs for 7 days. There will be follow-up visit between removal of a dual IVR and replacing it with a triple IVR.

Who may qualify

Ages: 18 to 45 years
Sex: Female only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (10 listed)

Provides written informed consent
Healthy female 18-45 years of age
HIV negative per subject report and results of screening examination
Negative for sexually transmitted diseases in the past 3 months and at screening exam
No history of genital herpes simplex I or II per subject report

Key exclusion criteria (14 listed)

HIV positive by subject report or results of screening examination
Positive history for autoimmune disease
Abnormal genital exam defined as grade 1 or higher adverse event by DAIDS genital AE grading table
Abnormal ALT or AST or Hepatitis B infection
Active vaginal infection as determined by site IoR

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
TDF IVRAlso: Single IVR	Drug	TDF (Single IVR)
TDF-FTC IVRAlso: Dual IVR	Drug	TDF-FTC (Dual IVR)
TDF-FTC-MVC IVRAlso: Triple IVR	Drug	TDF-FTC-MVC (Triple IVR)

Primary outcome

Number of Participants With Specific Graded Adverse Events in Single, Dual, and Triple Antiretroviral (ARV) Intravaginal Rings (IVRs)
Time frame: Days 0-21 following insertion of each IVR.
Number of Adverse Events (AEs) was recorded. Safety parameters were monitored for each IVR combination and the grading scale for each parameter followed the Female Genital Grading Table for Use in Microbicide Studies. AEs not included in that table were graded using the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 2.0, November 2014 (Grade 1 = mild, Grade 2 = Moderate, Grade 3 = Severe, Grade 4 = Potentially Life-Threatening).
Pharmacokinetics of the Single, Dual and Triple ARV IVRs: Cervicovaginal Fluid (CVF)
Time frame: Time points at which outcome measure was assessed are Days 2 (after IVR insertion) and 7 (day of IVR removal).
Drug concentrations [tenofovir (TFV), tenofovir disoproxil fumarate (TDF), emtricitabine (FTC) and maraviroc (MVC)] in cervicovaginal fluids (CVF) for each IVR combination.
Pharmacokinetics of the Single, Dual and Triple ARV IVRs: Cervicovaginal Lavage (CVL)
Time frame: Time points at which outcome measure was assessed are Days 2 (after IVR insertion) and 7 (day of IVR removal).
Drug concentrations [tenofovir disoproxil fumarate (TDF), emtricitabine (FTC) and maraviroc (MVC)] in cervicovaginal lavage (CVL) were evaluated for each IVR combination.
Pharmacokinetics of the Single, Dual and Triple ARV IVRs: Vaginal Tissue
Time frame: Time points at which outcome measure was assessed are Days 2 (after IVR insertion) and 7 (day of IVR removal).
Drug concentrations [tenofovir disoproxil fumarate (TDF), tenofovir (TFV), tenofovir diphosphate (TFV-DP), emtricitabine (FTC) and maraviroc (MVC)] in vaginal tissue (VT) were evaluated for each IVR combination.
Pharmacokinetics of the Single, Dual and Triple ARV IVRs: Plasma
Time frame: Time points at which outcome measure was assessed are Days 2 (after IVR insertion) and 7 (day of IVR removal).
Drug concentrations [tenofovir disoproxil fumarate (TDF), emtricitabine (FTC) and maraviroc (MVC)] in plasma were evaluated for each IVR combination.
Pharmacokinetics of the Single, Dual and Triple ARV IVRs: Terminal Half-life
Time frame: Time points at which outcome measure was assessed are Day 7 (day of IVR removal) and daily up to 14 days.
Drug concentrations [tenofovir disoproxil fumarate (TDF), emtricitabine (FTC) and maraviroc (MVC)] in terminal half-life were evaluated for each IVR combination.

1 secondary outcome

Acceptability of the IVRs
Time frame: Days 0-21 following insertion of each IVR.

Results and safety

Results posted to the registry on 2 Jul 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
TDF (Single IVR), TDF-FTC (Dual IVR), TDF-FTC-MVC (Triple IVR)	6	6

Primary outcome: Number of Participants With Specific Graded Adverse Events in Single, Dual, and Triple Antiretroviral (ARV) Intravaginal Rings (IVRs)

Time frame: Days 0-21 following insertion of each IVR.. Number. Unit: participants

Measure	Period 1: TDF (Single IVR) n = 6	Period 2: TDF-FTC (Dual IVR) n = 6	Period 3: TDF-FTC-MVC (Triple IVR) n = 6
Pelvic Pain: Grade 1	4	1	4
Pelvic Pain: Grade 2	1	1	0
Vaginal Discharge: Grade 1	3	3	1
Metrorrhagia: Grade 1	1	0	2
Vulvovaginal Itching: Grade 1	3	0	1
Cervicovaginal Erythema: Grade 1	3	1	0
Diarrhea: Grade 1	1	0	0
Malaise: Grade 1	1	0	0

Primary outcome: Pharmacokinetics of the Single, Dual and Triple ARV IVRs: Cervicovaginal Fluid (CVF)

Time frame: Time points at which outcome measure was assessed are Days 2 (after IVR insertion) and 7 (day of IVR removal).. Median (Inter-Quartile Range). Unit: ng/mg

Measure	Period 1: TDF (Single IVR) n = 6	Period 2: TDF-FTC (Dual IVR) n = 6	Period 3: TDF-FTC-MVC (Triple IVR) n = 6
tenofovir disoproxil fumarate	58.1 (43.9 to 97.4)	43.1 (31.0 to 65.0)	96.9 (14.5 to 137.1)
tenofovir	13.9 (6.2 to 19.3)	15.9 (7.1 to 20.0)	28.0 (24.3 to 31.9)
Total tenofovir	36.2 (31.3 to 60.6)	34.4 (26.9 to 48.7)	70.0 (59.2 to 80.6)
emtricitabine	NA (NA to NA)	896 (367.0 to 1349.0)	838.5 (641.8 to 1171.2)
maraviroc	NA (NA to NA)	NA (NA to NA)	429.8 (253.2 to 626.2)

Primary outcome: Pharmacokinetics of the Single, Dual and Triple ARV IVRs: Cervicovaginal Lavage (CVL)

Time frame: Time points at which outcome measure was assessed are Days 2 (after IVR insertion) and 7 (day of IVR removal).. Median (Inter-Quartile Range). Unit: ng/mL

Measure	Period 1: TDF (Single IVR) n = 6	Period 2: TDF-FTC (Dual IVR) n = 6	Period 3: TDF-FTC-MVC (Triple IVR) n = 6
tenofovir disoproxil fumarate	1,930 (1,040 to 2,290)	1,720 (1,028 to 3,429)	3,630 (2,310 to 15,700)
tenofovir	611 (242 to 2,440)	927 (315 to 1,253)	2,670 (1,668 to 4,175)

Primary outcome: Pharmacokinetics of the Single, Dual and Triple ARV IVRs: Vaginal Tissue

Time frame: Time points at which outcome measure was assessed are Days 2 (after IVR insertion) and 7 (day of IVR removal).. Median (Inter-Quartile Range). Unit: ng/mg

Measure	Period 1: TDF (Single IVR) n = 6	Period 2: TDF-FTC (Dual IVR) n = 6	Period 3: TDF-FTC-MVC (Triple IVR) n = 6
tenofovir	8.4 (4.7 to 11.2)	5.1 (0.8 to 10.1)	5.1 (3.3 to 9.7)
tenofovir diphosphate	303 (277 to 938)	289 (110 to 603)	301.9 (177.1 to 823.8)
emtricitabine	NA (NA to NA)	23,950 (11,373 to 56,400)	104 (63.7 to 301.7)
maraviroc	NA (NA to NA)	NA (NA to NA)	141.8 (82.5 to 212)

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Adverse event data was collected Days 0-21 following insertion of each IVR. Safety measures include: daily participant reports, colposcopy examinations, vaginal microbiome evaluations, or histology from vaginal biopsy.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
TDF (Single IVR)	0 of 6 (0%)	6 of 6 (100%)	0 of 6
TDF-FTC (Dual IVR)	0 of 6 (0%)	6 of 6 (100%)	0 of 6
TDF-FTC-MVC (Triple IVR)	0 of 6 (0%)	4 of 6 (66.7%)	0 of 6

Limitations and caveats (from the sponsor): The study's main limitations include the small sample size, short duration (7 days), and the lack of FTC triphosphate measurements in vaginal tissue biopsies.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 30265679Vincent KL, Moss JA, Marzinke MA, Hendrix CW, Anton PA, Pyles RB, Guthrie KM, Dawson L, Olive TJ, Butkyavichene I, Churchman SA, Cortez JM Jr, Fanter R, Gunawardana M, Miller CS, Yang F, Rosen RK, Vargas SE, Baum MM. Safety and pharmacokinetics of single, dual, and triple antiretroviral drug formulations delivered by pod-intravaginal rings designed for HIV-1 prevention: A Phase I trial. PLoS Med. 2018 Sep 28;15(9):e1002655. doi: 10.1371/journal.pmed.1002655. eCollection 2018 Sep.
Derived from this study: PubMed 27067321Moss JA, Butkyavichene I, Churchman SA, Gunawardana M, Fanter R, Miller CS, Yang F, Easley JT, Marzinke MA, Hendrix CW, Smith TJ, Baum MM. Combination Pod-Intravaginal Ring Delivers Antiretroviral Agents for HIV Prophylaxis: Pharmacokinetic Evaluation in an Ovine Model. Antimicrob Agents Chemother. 2016 May 23;60(6):3759-66. doi: 10.1128/AAC.00391-16. Print 2016 Jun.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Kathleen L Vincent, MD principal investigator

University of Texas Medical Branch (UTMB)

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing TDF IVR, TDF-FTC IVR and TDF-FTC-MVC IVR in people with Human Immunodeficiency Virus (HIV) Prophylaxis, run by Auritec Pharmaceuticals at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 2 Jul 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Specific Graded Adverse Events in Single, Dual, and Triple Antiretroviral (ARV) Intravaginal Rings (IVRs) (time frame: Days 0-21 following insertion of each IVR.). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02431273, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2019.